DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s amendments dated 08/13/2025 overcome the previously presented claim objections and rejection under 35 U.S.C. 112(b).
Applicant's arguments regarding the previously presented prior art rejections have been fully considered but they are not persuasive.
Applicant has argued that the Haq reference does not fairly teach a first wall element arranged between the first top section and the first base section and defining a corresponding internal lumen of the first primary container, in which the first wall element of the primary container is compressible with respect to the first top and first base sections, the wall element being composed of a flexible material and including one or more folds, namely, because Applicant alleges that Haq is directed to a roller bottle. This is found unpersuasive, as the Examiner asserts that Haq clearly discloses a top section (12), base section (16), and compressible fold-containing wall (14) arranged therebetween as claimed, as was discussed in the prior Office Action (p. 6). Applicant has not pointed to any specific differences between the claimed wall section and the wall section disclosed by Haq.
Applicant has argued that the Haq reference does not fairly teach one or more auxiliary containers, wherein each auxiliary container in the one or more auxiliary containers couples with a respective inlet or outlet on the first top section of the primary container, wherein each auxiliary container in the one or more auxiliary containers is external to the primary container and in fluid communication with the primary container, and wherein the one or more auxiliary containers is located on the first top section of the primary container; however, Haq was not relied upon for teaching this limitation. Rather, the Gebauer reference was relied upon for disclosure of the one or more auxiliary containers (see p. 5 of the prior Office Action), and applicant has not pointed to any specific deficiencies in the Gebauer reference in regards to the claimed one or more auxiliary containers.
Applicant has argued that modifying Gebauer in view of Haq would be unobvious because they are directed to different problems. This is found unpersuasive, because both references are directed to cell culture containers. Specifically, Haq discloses that the flexible wall provides the advantages of convenient storage when the wall is in the compressed state and allowing a user to select a size of the container by expanding the container to a desired degree by means of the folds in the flexible wall (see p. 6 of prior Office Action). These advantages are not found in Gebauer as Gebauer is silent as to a user having the ability to select a size of the container by means of a flexible wall, and therefore it would have been readily apparent to the skilled artisan to equip the cell culture container disclosed by Gebauer to have a flexible wall as in the Haq reference. As to Applicant’s argument that Haq teaches using the container to culture cells within the folds (Applicant cites Figs. 4a-4b of Haq, see pp. 11-12 of the Remarks), contrary to the operation contemplated by Gebauer, the Examiner asserts that this is merely an “exemplary use” contemplated by Haq (see para. 19), and by no means the only possible way of operating a cell culture container with a flexible wall. As to Applicant’s argument that Haq teaches a rigid container that would impact the operation of the system disclosed by Gebauer, which uses flexible components, this argument is not found persuasive, as Haq clearly discloses that rigid containers are suitable for culturing cells (Abstract, para. 15), and thus the Examiner asserts that incorporating characteristics of the Haq device such as the flexible wall would not impede cell culture as in the system of Gebauer.
Applicant’s amendment to claim 6 has necessitated a new grounds of rejection.
Applicant has not presented any arguments pertaining to the previous double patenting rejections, and therefore these rejections are maintained.
Claim Objections
Claim 6 is objected to because of the following informalities:
It is believed the last line of claim should read “configured to be detachably connected”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 6 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hatano et al. (JP 2006314276 A) (machine translation) (already of record).
Regarding claim 6, Hatano et al. discloses an auxiliary container (para. 1, 18, 30; the container can be used with other containers, see para. 58, and thus reads on being an auxiliary container), wherein the auxiliary container comprises a bottom planar surface (2) (reads on a second base section) (para. 18) (Figs. 1-2), a top planar surface (2) (reads on a second top section) arranged substantially in parallel with the second base section (para. 18) (Figs. 1-2), and side portions (reads on a second wall element) (para. 18) arranged between the top and bottom and defining a corresponding internal lumen of the auxiliary container (para. 18-21), wherein the side portions (second wall element) are compressible with respect to the top and bottom (para. 18-21, 32-33) (Figs. 1-2), wherein the container has at least one optionally sealable inlet (para. 23), wherein the side portions (second wall element) are composed of a flexible material (para. 18); and wherein the auxiliary container is configured to be detachably connected to an inlet or outlet of another container (para. 23, 58) (Fig. 12).
As to the limitation of wherein the auxiliary container is for use with the device as defined in claim 1 and configured to be detachably connected to the respective inlet or outlet of the primary container, this is directed to an intended use of auxiliary container and has been given appropriate patentable weight. It is noted that claim 6 covers only an auxiliary container and does not define a device that comprises the device of claim 1. The container disclosed by Hatano et al. is fully capable of being used with a device as defined in claim 1, and more specifically, to be detachably connected to the respective inlet or outlet of the primary container of the device as defined in claim 1, because it comprises a tubing and/or connector that can be detachably connected to an inlet or outlet of another container (para. 23, 58) (Fig. 12), and therefore Hatano et al. meets the limitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 5, 7, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gebauer et al. (WO 2015180908 A1) (US Patent Application Publication 2017/0044477, an English language equivalent, will be cited herein) (already of record) in view of Haq (US Patent Application Publication 2007/0224676) (already of record).
Regarding claim 1, Gebauer et al. discloses a device for use in culturing cells (Abstract), the device comprising a collapsible primary container (one of a plurality of bags in a stack, e.g., a second bag) (para. 22, 26) having a first base section (bottom section) (para. 23, 26, 28), a first top section arranged substantially in parallel with the first base section (para. 23, 26, 28) (Fig. 8, sheet 8 of 10; Fig. 10, sheet 10 of 10), and in which the primary container has at least one sealable inlet (para. 26), in which the primary container is composed of a flexible material (Abstract); and wherein the device further comprises an auxiliary container (e.g., third bag stacked on top of second bag) (para. 26), wherein the auxiliary container couples with a respective inlet or outlet on the first top section of the primary container (para. 22, 26) (Fig. 8, sheet 8 of 10), wherein the auxiliary container is external to the primary container and in fluid communication with the primary container (para. 22, 26) (Figs. 4-8, sheets 4-8 of 10), and wherein the auxiliary contain is located on the first top section of the primary container (e.g., third bag stacked on top of second bag as discussed above; see also para. 22, 26, and Figs. 4-8, sheets 4-8 of 10).
Gebauer et al. is silent as to the primary container having a first wall element arranged between the first top section and the first base section and defining a corresponding internal lumen of the first primary container, in which the first wall element of the primary container is compressible with respect to the first top and first base sections, the wall element being composed of a flexible material and including one or more folds.
Haq discloses a container for cell growth culturing (Abstract) comprising a base section (16), a top section (12), and a first wall element (14) arranged between the top section and base section and defining a corresponding internal lumen of the container (para. 11) (Fig. 1, sheet 1 of 3), in which the wall element is compressible with respect to the top and base sections (para. 12-13), the wall element being composed of a flexible material and including a plurality of folds (para. 12-13) (Figs. 1-2, sheet 1 of 3). Haq et al. discloses forming the container in such a manner allows it to be stored and transported in a compressed state, providing the advantage of higher density of storage and transportation of containers (para. 23). The container may then be expanded by means of the wall element into a size chosen by the user for a cell culture application (Abstract, para. 13).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the primary container disclosed by Gebauer et al. to comprise a first wall element arranged between the first top section and the first base section and defining a corresponding internal lumen of the first primary container, in which the first wall element of the primary container is compressible with respect to the first top and first base sections, the wall element being composed of a flexible material and including a plurality of folds, based on the teachings of Haq, given that Gebauer et al. already discloses forming the container as collapsible as discussed above, and because the skilled artisan would have been motivated to obtain the advantage of storing and/or transporting a higher density of containers prior to usage using a known configuration.
Regarding claim 2, Gebauer et al. discloses wherein the auxiliary container comprises a second base section (bottom section) (para. 23, 26, 28) configured to detachably connect to the respective inlet or outlet of the primary container (para. 22, 26).
Regarding claim 5, Gebauer et al. discloses an auxiliary container located near the first base section of the primary container (first bag on which the second bag is stacked) (para. 26) (Figs. 4-8, sheets 4-8 of 10).
Regarding claim 7, Gebauer et al. discloses wherein the auxiliary container is collapsible (para. 22) and comprises a second base section (bottom section) (para. 23, 26, 28), a second top section arranged substantially in parallel with the first base section (para. 23, 26, 28) (Fig. 8, sheet 8 of 10; Fig. 10, sheet 10 of 10), in which the auxiliary container has at least one sealable inlet (para. 26), in which the auxiliary container is composed of a flexible material (Abstract); and wherein the auxiliary container is configured to detachably connect to the respective inlet or outlet of the primary container (para. 22, 26).
Gebauer et al. is silent as to the auxiliary container having a second wall element arranged between the second top section and the second base section and defining a corresponding internal lumen of the auxiliary container, in which the second wall element of the auxiliary container is compressible with respect to the second top and second base sections, the wall element being composed of a flexible material.
Haq discloses a container for cell growth culturing (Abstract) comprising a base section (16), a top section (12), and a first wall element (14) arranged between the top section and base section and defining a corresponding internal lumen of the container (para. 11) (Fig. 1, sheet 1 of 3), in which the wall element is compressible with respect to the top and base sections (para. 12-13), the wall element being composed of a flexible material (para. 12-13) (Figs. 1-2, sheet 1 of 3). Haq et al. discloses forming the container in such a manner allows it to be stored and transported in a compressed state, providing the advantage of higher density of storage and transportation of containers (para. 23). The container may then be expanded by means of the wall element into a size chosen by the user for a cell culture application (Abstract, para. 13).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the auxiliary container disclosed by Gebauer et al. to comprise a second wall element arranged between the second top section and the second base section and defining a corresponding internal lumen of the auxiliary container, in which the second wall element of the auxiliary container is compressible with respect to the second top and second base sections, the wall element being composed of a flexible material, given that Gebauer et al. already discloses forming the container as collapsible as discussed above, and because the skilled artisan would have been motivated to obtain the advantage of storing and/or transporting a higher density of containers prior to usage using a known configuration.
Regarding claim 17, Gebauer et al. discloses the primary container and an auxiliary container, as set forth above. Gebauer et al. further discloses wherein the auxiliary container comprises a second base section (bottom section) configured to be in direct fluid communication with the primary container (para. 26) (Figs. 4-8, sheets 4-8 of 10).
Gebauer et al. further discloses an embodiment with ”one larger bag placed below or on top of the two or three bags” (para. 26).
Therefore, the limitation of a plurality of auxiliary containers, wherein the second base section of some of the auxiliary containers in the plurality are independently configured to be in direct fluid communication with the primary container, is obvious in view of Gebauer et al., as Gebauer et al. discloses a plurality of auxiliary containers stacked atop a primary container, and placing an auxiliary container in fluid communication with the primary container upon which it is stacked, and the skilled artisan would have been motivated to combine these two features into a single embodiment in order to place cell culture containers into communication in parallel, thereby enhancing the throughput operation of the device.
Regarding claim 19, Gebauer et al. in view of Haq teaches the one or more folds, as set forth above, wherein Haq discloses that the folds are z-folds (Fig. 1, sheet 1 of 3); therefore, the prior art combination arrives at the claimed subject matter.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gebauer et al. (WO 2015180908 A1) (US Patent Application Publication 2017/0044477, an English language equivalent, will be cited herein) (already of record) in view of Haq (US Patent Application Publication 2007/0224676) (already of record) as applied to claim 1, above and in further view of Miersch et al. (US Patent Application Publication 2002/0104265) (already of record).
Regarding claim 8, Gebauer et al. discloses the auxiliary container, as set forth above, and further discloses that it is desirable to control the temperature within the container for sensitive cell cultures (para. 4).
Gebauer et al. is silent as to the auxiliary container comprising insulation configured to maintain the contents of that auxiliary container at a particular temperature.
Miersch et al. discloses an apparatus comprising flexible container for processing biomass therein (para. 14-18). Miersch et al. discloses that the apparatus further comprises an insulating robe placed over the flexible container to ensure that temperature conditions within the container remain sufficiently high for biomass reactions to proceed (para. 21, claim 6).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the auxiliary container disclosed by Gebauer et al. to comprise an insulating robe (reads on the claimed insulation), as Miersch et al. discloses that it was known in the art to provide such an element over a flexible bioprocessing container to retain heat therein, and the skilled artisan would have been motivated to prevent heat loss from the container to ensure that the temperature therein remains appropriate for cell culture.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 5-10, 17, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8 of U.S. Patent No. 11,993,765. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, claim 1 of the reference patent recites the same subject matter verbatim, with the addition of subject matter relating to direct fluid communication and a valve.
Regarding claim 2, claim 2 of the reference patent recites the same subject matter.
Regarding claim 5, claim 1 of the reference patent recites the same subject matter with the exception that the one or more auxiliary containers are on the first top section of the primary container rather than at or near the first base section of the primary container. Nonetheless, this different does not introduce a patentable distinction, as it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP §2144.04), and that the rearrangement of parts of a prior art device, wherein the rearrangement does modify the operation of the device, is an obvious matter of design choice (MPEP §2144.04). It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the device according to claim 1 of the reference patent to include one or more auxiliary containers at or near the first base section of the primary container, as such a modification represents mere duplication and placement of auxiliary containers in another location, which would yield the predictable and advantageous result of allowing a higher throughput of fluid.
Regarding claim 6, claim 3 of the reference patent recites the same subject matter.
Regarding claim 7, claim 3 of the reference patent recites the same subject matter.
Regarding claim 8, claim 4 of the reference patent recites the same subject matter.
Regarding claim 9, claim 5 of the reference patent recites the same subject matter.
Regarding claim 10, claim 6 of the reference patent recites the same subject matter.
Regarding claim 17, claim 3 of the reference patent recites the same subject matter.
Regarding claim 19, claim 8 of the reference patent recites the same subject matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799